Korean OBEsity Surgical Treatment Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

Brief Summary

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This trial is a multi-center, single-arm, prospective, observational cohort study of patients undergoing primary bariatric surgical procedures in Korea. A total of 100 patients will be recruited over a 1-year period from 2016 to 2017, and will be followed for a mean follow-up period of 1 year after surgery. The eligible subjects who have given their consent to participate will undergo one of two surgical procedures; sleeve gastrectomy and Roux-en Y gastric bypass.

The primary objective of this clinical trial is to measure the changes in body weight (kg) and waist circumference (cm) of the enrolled patients at postoperative 1 year. Secondary outcomes are improvement or remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea), and the change in quality of life. Additionally, postoperative incidences of morbidity and mortality, micronutrient status, body composition, and cost-effectiveness of surgical intervention will be examined.

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Detailed Description

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Conditions

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Bariatric Surgery Candidate Obesity, Morbid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bariatric surgery

This trial is a single-arm study and the enrolled patients are going to undergo sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB).

If the patient has Barrett's esophagus on the preoperative endoscopy, SG is not permitted. Inflammatory bowel disease and Helicobacter pylori infection on a rapid urease test are contraindications of RYGB.

Group Type EXPERIMENTAL

Sleeve gastrectomy or Roux-en-Y gastric bypass

Intervention Type OTHER

Interventions

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Sleeve gastrectomy or Roux-en-Y gastric bypass

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. body mass index (BMI) ≥ 35 kg/m2 or BMI ≥ 30 kg/m2 with co-morbidities such as hypertension, glucose intolerance, dyslipidemia, and sleep apnea
2. being suitable for general anesthesia
3. being able to give informed consent and committed to follow-up
4. Female patients should have a negative urine pregnancy test at screening and agree to use reliable method of contraception for 1 year.

Exclusion Criteria

1. prior bariatric surgery of any kind
2. being unable to understand the risks, benefits and compliance requirements of this trial
3. pregnancy or planning on being pregnancy
4. non-Korean speaker
5. American society of anesthesiology (ASA) class IV or higher
6. malignancy within 5 years.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No